Recruiting enough participants and keeping them engaged through lengthy clinical trials is increasingly challenging. In fact, more than 80% of trials in the US fail to meet their enrolment targets.
Globally, more than half of trials end early due to insufficient participant recruitment. Even when studies do enrol enough patients, retaining them is hard. Dropout rates reach as high as 30%. Such attrition not only jeopardises the scientific validity of results but also drives up costs.
Trial protocols themselves are also becoming more complex each year, with regulatory demands and scientific ambitions increasing the number of procedures and data points collected.
One analysis found that the average Phase III trial now has approximately 35 distinct procedures, up 59% from a decade earlier. Similarly, the total number of trial protocol procedures has increased by ~65% in the past ten years, lengthening study visits and increasing the burden on both sites and patients. This rising complexity, combined with strict eligibility criteria and burdensome schedules, makes it more difficult for participants to stay on track.
Digital solutions to clinical trial challenges
In response to these pressures, clinical trials are turning to digital innovations such as electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA).
These technologies replace paper questionnaires and diaries with digital interfaces, typically on smartphones, tablets, or web browsers, through which patients can report symptoms, side effects, and quality-of-life data in real-time. By moving patient-reported data collection to electronic platforms, sponsors aim to make trials more efficient and patient-friendly.
In traditional setups, if electronic data capture (EDC) and ePRO are separate systems, sites often grapple with multiple logins, duplicate databases, and delayed data transfers. Viedoc rectifies this issue with its unifying approach, combining EDC and ePRO on the same clinical database.
鈥淐ompared to other vendors, where you have the EDC and ePRO separately, with two databases that need to sync, under our umbrella we have the EDC and the ePRO all talking to the same clinical database,鈥� says Majd Mirza, chief innovation officer at Viedoc.
This means the instant a patient saves an ePRO entry, investigators can pull it up in the EDC with zero synchronisation delay. The data is unified, live, and available to site staff in real time, so there is no risk of updates getting lost in transit or out of sync.
An integrated design also simplifies study builds, with ePRO questionnaires set up within the same study build interface as other case report forms, avoiding duplicate work and potential inconsistencies, even if protocol amendments are made.
鈥淚t鈥檚 easier for the patients and the sites to collect the data. Everything is captured directly by the patient and immediately visible, without paper transcription or delays,鈥� adds Maria Axetun from Viedoc. She further highlights the importance of human factors. 鈥淭he study team also needs to be engaged in developing the study and supporting the sites, especially if they鈥檙e transitioning from paper to digital,鈥� she adds.
Jessica Nilsson, product manager at Viedoc, emphasises the importance of ease of use for this transition 鈥淚t鈥檚 a browser-based solution. You don鈥檛 need to install anything, it works on phones, tablets, or laptops,鈥� she says. 鈥淭hat really helps raise engagement because patients can use the device they鈥檙e most comfortable with.鈥�
Perhaps most importantly, a unified ePRO/EDC platform improves data quality and compliance by streamlining the user experience for both patients and site personnel.
鈥淲e can configure alerts or text messages to be sent directly to the subject,鈥� says Flordelyn Cobar Lundgren, project manager at Viedoc. 鈥淭hey can be set to trigger at specific times or only when data hasn鈥檛 been submitted, depending on what the study requires.鈥�
Participants can also update their contact information directly within the app, enhancing autonomy and ensuring continuous and accurate communication. Site staff can log in and see immediately if a patient has missed any ePRO entries and can take action, such as a follow-up call. This proactive data monitoring simply isn鈥檛 possible with paper forms that might not surface until the next clinic visit. As a result, protocol compliance improves.
Embracing the digital future of clinical trials: The rise of patient-centric design
Looking ahead, trial professionals should watch for continued innovation in patient-centric design. ePRO and eCOA tools will likely become even more engaging, borrowing ideas from social media, gaming, and personalised medicine to keep patients motivated.
A guiding principle for these innovations is to make participation as easy and seamless as possible for patients. Unified patient portals that provide a single login can consolidate all study-related activities in one place 鈥� allowing participants to see at a glance what is expected of them, give consent, complete questionnaires, access personalised study information, and communicate directly with the site team whenever required.
Mirza emphasises this forward-thinking approach. 鈥淲e鈥檝e been starting to play with AI chatbots trained on study material so the patient has 24/7 access to a support assistant that can answer questions in any language,鈥� he says.
Multilingual support is particularly beneficial for global trials, and electronic systems can easily deploy the same questionnaire in dozens of languages, ensuring patients can report outcomes in their native tongue. Viedoc鈥檚 ePRO interface supports more than 50 languages, both in the system menus and the questionnaires themselves
Nilsson also sees gamification as a significant part of future improvements. 鈥淧atient engagement is the thing right now, and we see gamification as a significant part of future improvements,鈥� she says.
This gamification refers to incorporating elements such as think points, badges, progress bars, and friendly competitions or challenges. The goal isn鈥檛 to turn serious clinical research into a videogame but rather to tap into motivational triggers that make participation feel rewarding.
For example, an ePRO app might display a progress bar or 鈥渟treak鈥� counter to show a patient how many days in a row they鈥檝e completed their diary, encouraging them to keep the going. It might award a virtual badge or send a congratulatory message when they hit a milestone.
Decentralised trial models, which gained momentum during the pandemic, will rely heavily on these digital reporting tools since visiting the clinic in person less often means the data pipeline from patients鈥� homes must be reliable. We can also expect greater integration across systems. ePRO platforms talking directly to electronic health records, wearables feeding into eCOA data streams, and analytics dashboards giving study teams real-time oversight of both efficacy and safety outcomes.
By reducing burdens and meeting patients where they are 鈥� on their own devices, in their own languages, with support at their fingertips 鈥� ePRO and eCOA are helping to humanise clinical trials. As these tools continue to evolve with features such as gamification and AI assistance, clinical trial professionals have an opportunity to reimagine how studies are run.
To find out more about how Viedoc can support your clinical trial, access the video below.
